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EORTC QLQ-BR23 and FACT-B for the

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EORTC QLQ-BR23 and FACT-B for the

assessment of quality of life in patients
with breast cancer: a literature review

Background: This study aims to compare the development, characteristics and validity Jasmine Nguyen1, Marko
of two widely used tools in the breast cancer population, the EORTC QLQ-BR23 Popovic1, Edward Chow*,1,
and the FACT-B. Methods: A literature search was conducted using Ovid MEDLINE, David Cella2, Jennifer L
OLDMEDLINE, Embase, Embase Classic and the Cochrane Central Register of Controlled Beaumont2, Dominic Chu1,
Julia DiGiovanni1, Henry
Trials to identify relevant studies. Results: Both tools were found to be reliable and
Lam1, Natalie Pulenzas1 &
valid. The QLQ-BR23 focuses on physical function, whereas the FACT-B emphasizes
Andrew Bottomley3
emotional well-being. Scoring, item format, organization and response options differ 1
Rapid Response Radiotherapy Program,
between questionnaires. Conclusion: Overall, both questionnaires are effective Department of Radiation Oncology,
in assessing breast cancer-specific quality of life. Clear similarities and differences Odette Cancer Centre, Sunnybrook
between the two tools exist. Decision-making between the questionnaires should be Health Sciences Centre, University of
Toronto, 2075 Bayview Avenue, Toronto,
based on the purpose and design of the study.
Ontario M4N 3M5, Canada
2
Department of Medical Social Sciences,
Keywords: breast cancer EORTC FACT quality of life Northwestern University Feinberg School
of Medicine, Chicago, IL, USA
3
European Organisation for Research
Breast cancer is the most prevalent cancer cancers multifaceted burden, it is imperative & Treatment of Cancer Headquarters,
in Canada and is the second leading cause that clinicians record and utilize patients Brussels, Belgium
of death amongst females[1] . With improve- QoL in clinical decision-making. *Author for correspondence:
ments in screening methods and treatment Two widely used QoL questionnaires appli- Tel.: +1 416 480 4998
Fax: +1 416 480 6002
modalities, 5-year survival rates have now cable to all cancer patients are the European
edward.chow@sunnybrook.ca
increased to above 80%[2] . Organisation for Research and Treatment of
In its early stages, breast cancer is often Cancer (EORTC) Quality of Life Question-
asymptomatic. Symptoms appear as the naire (QLQ) C30 and the Functional Assess-
tumor progresses and can include a lump in ment of Cancer Therapy-General (FACT-G).
the breast or axilla, tenderness and a change Although certain QoL issues, such as pain and
in the size, shape, texture or temperature of fatigue[7] , are addressed in general QoL ques-
the breast[3] . Treatments include chemother- tionnaires, breast cancer patients also identify
apy, radiation therapy, surgery and endocrine with more unique concerns, such as feelings
treatment. Prognosis and survival are not the of decreased attractiveness and femininity, as
sole concerns of breast cancer patients as cos- well as treatment-related arm symptoms[8,9] .
metic alterations due to treatment and the These specific concerns encouraged the devel-
disease itself can have profound effects on opment of two breast cancer-specific QoL
their psychosocial morbidity[4] . modules: the EORTC QLQ-BR23, which is
Quality of life (QoL) is an established used in conjunction with the EORTC QLQ-
prognostic indicator in breast cancer[5] . It is C30, and the FACT-Breast (FACT-B), which
a multidimensional, subjective construct that incorporates the FACT-G along with a Breast
reflects physical, mental and social health Cancer Subscale (BCS).
domains to provide a complete representation Currently, the EORTC QLQ-BR23 and
of patient well-being[6] . Given the prognostic the FACT-B are the only two modules that
significance of QoL in a patient population specifically examine the QoL of breast cancer
part of
with favorable median survival rates and the patients. Despite the increasing significance

10.2217/CER.14.76 2015 Future Medicine Ltd J.Comp. Eff. Res. (2015) 4(2), 157166 ISSN 2042-6305 157
Review Nguyen, Popovic, Chowet al.
of QoL, there has not yet been a consensus on whether
the EORTC QLQ-BR23 or FACT-B is most favorable
in present-day clinical trials. Comparison between the
current breast-specific tools available today can help
clinicians choose pertinent questionnaires for their
investigations. As such, the objective of this study is
to compare two widely used breast cancer-specific
QoL questionnaires, the EORTC QLQ-BR23 and the
FACT-B, with respect to their developmental process,
reliability, validity and characteristics.
Methods
A literature search was conducted using Ovid MED-
LINE and OLDMEDLINE (1946 to July week 1 2013),
Ovid Embase and Embase Classic (1947 to 2013 Week
28) and the Cochrane Central Register of Controlled
Trials (-June 2013). The utilized keywords included:
EORTC, questionnaire, survey, instrument, assess- items that were divided into five scales: two functional
ment, evaluate, QLQ, FACT-B, breast cancer and scales (body image and sexuality) and three symptom
breast tumor. Included articles addressed at least one of
the following aspects: development, reliability testing,
validity testing, characteristics and utilization in trials
worldwide. Non-English studies were excluded.
Results
A literature search for conventional intervention-
related trials utilizing the FACT-B or the EORTC
QLQ-B23 yielded 67 results for FACT-B and 86 results
for the EORTC QLQ-BR23. The opposite pattern was
found when the same search for complementary and
alternative intervention trials was conducted, which
yielded 47 results for the FACT-B and 35 results for
the EORTC QLQ-BR23 (Table1) .
Initial development
The development of the EORTC QLQ-BR23 was first
described by Sprangersetal. in 1996[10] as the ques- not to complete them. The average time required to
tionnaire was in its second version. The development
of the QLQ-BR23 followed guidelines established by
the EORTC Study Group[11] , who describe modular
development to consist of four distinct phases. This
module was developed primarily by the Danish, Dutch
and American members of the Study Group.
In Phase I, a provisional list of relevant QoL issues
was generated by virtue of four sources: extensive lit-
erature searches, existing QoL questionnaires, breast
cancer physicians and patients themselves given
Table 1. Identified trials reporting the use of either the EORTC QLQ-BR23 or the FACT-B.
Trial use in conventional treatment (surgery/chemotherapy/
radiotherapy/endocrine treatment) trials
Trial use in complementary/alternative treatment trials
158 J.Comp. Eff. Res. (2015) 4(2)
that patient input is integral to QoL. These sources
imparted a prospective module comprising 26 issues.
In Phase II, these 26 issues were operationalized
into questionnaire items. The items were made brief
and unambiguous, conditional questions were broken
down into their components, and items addressing pos-
itive and negative concerns were worded positively and
negatively, respectively[12] . Items on body image were
pulled from a ten-item scale devised by Hopwood[13]
and the resulting module contained 35 items.
In Phase III, the provisional module was pretested
amongst a new sample of patients to obviate potential
problems. The sample comprised 23 Dutch and 110
Danish patients. Overall, the questionnaire was well
received for its clarity and relevance. However, because
some sexuality and body items were found to be exces-
sively personal, the questionnaire was reduced to 23
scales (arm symptoms, breast symptoms and systematic
side effects).
Prior to Phase IV, the module was translated from
Dutch into English. Upon further review, five items were
modified to reduce ambiguity. To achieve successful
cross-cultural application, pilot testing was conducted
among 13 British patients and 15 American patients
and minor syntax changes were carried out. The English
version was then approved and subsequently translated
into Spanish.
Phase IV was characterized by large scale interna-
tional field-testing for reliability, validity and cross-cul-
tural applicability using a Dutch, American and Span-
ish sample. Overall, the items were well accepted and
found to be feasible for the majority of patients with
the exception of 19% of women, who found the items
relating to sexuality overly intrusive, irrelevant or chose
complete the EORTC pair was approximately 9min.
In comparison, the developmental process of the
FACT-B was illustrated by Bradyetal.[14] in 1997 as the
FACT-G was in its third version. The original develop-
ment of the first version and the modifications that led to
versions 2 and 3 are described by Cellaetal.[1517] . Fol-
lowing the standard developmental process of the Func-
tional Assessment of Chronic Illness Therapy (FACIT)
questionnaires [18] , the development of FACT-B was
conducted in four phases.
EORTC QLQ-BR23 FACT-B
86 67
35 47
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 EORTC QLQ-BR23 & FACT-B for the assessment of quality of life in patients with breast cancer
Phase I of development entailed item generation.
Five healthcare professionals conducted extensive
interviews with 15 breast cancer patients to generate a
comprehensive list of significant issues. These patients
were chosen based on the following criteria: stage III
or IV breast cancer; treatment including chemotherapy
and/or radiotherapy; fluency in English and ability to
comprehend and participate in the interview. These
interviews accumulated 137 prospective items.
In Phase II, item reduction was achieved to ensure item
relevance to patient values. Thirty breast cancer patients
were asked to rate the items importance on a four-point
scale. Questions receiving a score of 3 and over were
retained. This list was then trimmed to nine items after
being reviewed by an expert panel as items overlapping
with those within the FACT-G were discarded.
Phase III involved scale construction. After exten-
sive testing, an item, I want to encourage other women
to examine their breasts was replaced with I am able
to feel like a woman due to its poor fit with the rest of
the subscale. The module was subsequently translated
into Spanish, Dutch, French, German, Italian, Nor-
wegian and Japanese following the translation proce-
dures described by Bonomietal. [19] . This resulting
module comprised 44 items divided into subscales that
assessed physical well-being (PWB), emotional well-
being (EWB), social well-being (SWB), functional
well-being (FWB) and the patients relationship with
[his/her] doctor (RWD).
In Phase IV, larger scale testing was incorporated.
Two American samples were analyzed to determine
the reliability and validity of the FACT-B. Overall, the
questionnaire was well regarded for its sensitivity to
change in clinical status over time, brevity, relevance
to patient values and stability across administrations.
The average time required to complete the FACT-B
was 10 min.
Recent development
Recently, the FACT-B has progressed from its third ver-
sion described by Bradyetal. [15] to its fourth version.
In its fourth version, the RWD domain was removed
from the FACT-G, leaving four domains: PWB, SWB,
EWB and FWB. Along with the RWD domain, items
#8 (Looking at the above seven questions, how much
would you say your physical well-being affects your
quality of life?), #16 (Looking at the above seven
questions, how much would you say your social/family
well-being affects your quality of life?), #19 (Look-
ing at the above two questions, how much would you
say your relationship with the doctor affects your qual-
ity of life?), #26 (Looking at the above six questions,
how much would you say your emotional well-being
affects your quality of life?) and #34 (Looking at the
future science group
Review
above seven questions, how much would you say your
functional well-being affects your quality of life?)
were deleted.
Modifications to the FACT-G were also made. One
item, I am satisfied with my sex life, under the SWB
domain of the FACT-G became nonconditional. This
item was to be answered regardless of level of sexual
activity within the fourth version but the option of not
answering the question was introduced. In the BCS,
one item examining regional pain (I have certain parts
of my body where I experience pain) was added to the
previously nine-item subscale. To further address the
occurrence of arm morbidity associated with surgi-
cal removal or sampling of axillary lymph nodes, a
symptom-specific four-item arm scale was developed to
supplement the FACT-B, forming the FACT-B+4[20] .
Additionally, a new eight item symptom index, the
Functional Assessment of Cancer Therapy Breast
Symptom Index[21] , was developed separately as a
more direct approach to measuring and analyzing QoL
scores in breast cancer patients and provides less room
for the interpretation of results.
As of August 2013, the EORTC QLQ-BR23 has
been translated into 53 different languages[22] , while
the FACT-B has been translated into 49 (Box1)[23] .
Reliability & validity
Validity
The validity of the EORTC QLQ-BR23 has been
internationally scrutinized and explored in countries
such as Iran[24] , Korea[25] , Mexico[26] and Greece[27] ,
which has ultimately confirmed the questionnaires
validity.
Sprangersetal.[11] utilized three methods to evaluate
the questionnaires validity: multitrait scaling; known-
groups comparison and one-way analysis of variance
(ANOVA). Analyses were performed on a 218-patient
Dutch sample, a 176-patient Spanish sample and a
158-patient American sample.
Multitrait analysis was used to confirm item-con-
vergence. Item-convergent validity is achieved when a
correlation of 0.40 or over is met. All three samples
exceeded the 0.40 criterion for body image and sexual
functioning; only the American and the Dutch sample
achieved item-convergent validity for the breast symp-
tom scales and only the American sample found item-
convergent validity in the arm symptoms scale. Prob-
lems were consistently found only in the systemic side
effects scale.
Discriminant validity was analyzed via known-
groups comparison. Comparisons between patients
with versus without metastatic disease portrayed that
statistically significant differences (p<0.001) were
found only within the sexual functioning, future per-
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Review Nguyen, Popovic, Chowet al.

Box 1. List of translations by language for Box 1. List of translations by language for
the European Organisationfor Research the European Organisationfor Research
and Treatment of Cancer Quality of Life and Treatment of Cancer Quality of Life
Questionnaire for Patients with Breast Cancer Questionnaire for Patients with Breast Cancer
and the Functional Assessment of Cancer and the Functional Assessment of Cancer
Therapy Quality of Life Measurement of Therapy Quality of Life Measurement of
Patients with Breast Cancer. Patients with Breast Cancer (cont.).
EORTC QLQ-BR23 EORTC QLQ-BR23 (cont.)
Afrikaans Spanish (Colombia)
Arabic Spanish (Costa Rica)
Bengali Spanish (Guatemala)
Bosnian Spanish (Mexico)
Bulgarian Spanish (Panama)
Chinese Mandarin (China) Spanish (Peru)
Chinese Mandarin (Singapore) Spanish (US)
Chinese Cantonese (HK) Swedish
Chinese Mandarin (Taiwan) Tagalog
Croatian Tamil
Czech Tamil (Malaysia)
Danish Tamil (Sri Lanka)
Dutch Telugu
Finnish Thai
French Turkish
French (Canada) Ukranian
Georgian Urdu (India)
German Vietnamese
Greek Xhosa
Guajarati Yoruba
Hebrew Zulu
Hindi FACT-B
Hungarian Afrikaans
Italian Arabic
Japanese Bengali
Kannada Bulgarian
Korean Chinese (Simplified)
Latvian Chinese (Traditional)
Lithuanian Croatian
Malay (Malaysia) Czech
Malay (Singapore) Danish
Malayalam (India) Dutch
Marathi English
Norwegian Estonian
Persian Finnish
Polish French
Portugese German
Portugese (Brazil) Greek
Punjabi Gujarati
Romanian Hebrew
Russian Hindi
Serbian Hungarian
Sinhala Italian
Slovak Japanese
Slovenian Kannada
Sotho (Africa) Korean
Spanish (Spain) Latvian
Spanish (Argentina) Lithuanian
Spanish (Chile) Malay

160 J.Comp. Eff. Res. (2015) 4(2) future science group

 EORTC QLQ-BR23 & FACT-B for the assessment of quality of life in patients with breast cancer
Box 1. List of translations by language for
the European Organisationfor Research
and Treatment of Cancer Quality of Life
Questionnaire for Patients with Breast Cancer
and the Functional Assessment of Cancer
Therapy Quality of Life Measurement of
Patients with Breast Cancer (cont.).
FACT-B (cont.)
Malayalam
Marathi
Norwegian
Polish
Portuguese
Punjabi
Romanian
Russian
Serbian
Slovak
Slovene
Spanish
Swedish
Tagalog
Tamil
Telugu
Thai
Turkish
Ukraine
Urdu
Vietnamese
Zulu
spective and systemic therapy side effects scales for the
Dutch patients and the systemic side effects scale for the
Spanish sample (p<0.01) when comparisons between
patients with versus without metastatic disease were
made. With respect to previous surgery, significantly
poorer body image (p<0.001) was found amongst
patients who had received mastectomy in the Dutch
and Spanish samples than in those who had under-
gone breast-conserving surgery. When initial KPS was
used as a grouping variable, poorer performance status
was associated with significantly lower levels of body
image, sexual functioning, future perspective and a
higher level of systemic therapy side effects (p<0.001
for all analyses). Another distinguishing variable used
was treatment choice. Patients receiving radiotherapy
reported a significantly higher level of breast symptoms
within the Dutch and Spanish samples (p<0.001),
whereas patients undergoing chemotherapy reported
a significantly higher level of systemic therapy side
effects in all three samples (p<0.01).
Clinical validity was further investigated by testing
the instruments ability to reflect changes in patients
KPS scores and treatment over time via repeated-mea-
sures ANOVA. This ability was found to only apply to
future science group
Review
the systematic therapy side effects scale (p<0.01) for
the Dutch patients and to the body image scale in the
Spanish sample (p<0.001). Patients receiving radio-
therapy reported higher levels of breast symptoms,
while those who underwent chemotherapy reported
higher levels of systemic therapy side effects over time.
Validation of the FACT-B has been well documented
by Bradyetal.[14] , who utilized two American samples
for validity and reliability testing. The first sample
consisted of 47 breast cancer patients who completed
the FACT-B to assess the instruments sensitivity to
change over a 2-month period and its concurrent valid-
ity through another QoL instrument, the Functional
Living Index-Cancer (FLIC), and divergent validity
through the Marlow-Crown Social Desirability Scale
(MCSDS). The second sample consisted of 295 breast
cancer patients who completed the FACT-B as part of a
3-year validation study of the FACT measurement sys-
tem. This sample was used for further reliability and
validity analyses.
Four types of validity were tested amongst the two
samples: sensitivity to change, convergent validity,
divergent validity and known-groups validity. Uni-
variate analyses displayed the instruments sensitivity to
change in performance status with respect to its total
score and the following subscales: PWB, FWB and the
BCS. The FACT-B significantly correlated with the
FLIC in terms of its total score (p<0.001), the FACT-
G total score (p<0.001) and its BCS score (p<0.001),
exhibiting its convergent validity. Divergent validity
was displayed as the correlation between the FACT-B
and the MCSDS was minimal, which was as expected
due to both instruments differing concepts. This find-
ing also indicates that FACT-B scores are not affected by
answers that patients feel are socially desirable, further-
ing its validity. Known-groups validity was supported
when the FACT-B differentiated between groups of
differing Eastern Cooperative Oncology Group per-
formance status ratings (ECOG PSR) via univariate
ANOVA (p<0.001). With exception of the two-item
RWD subscale, all subscales were able to distinguish
groups based on PSR.
Reliability
Sprangers etal. [10] assessed the internal consistency
of the QLQ-BR23 using Cronbachs coefficient.
A magnitude of 0.70 was sought, indicating that the
items in each scale highly correlated with one another
compared with items of another scale. The coefficients
were lowest within the Spanish sample, ranging from
0.46 to 0.94, intermediate within the Dutch sample,
ranging from 0.57 to 0.89, and highest within the
American sample, ranging from 0.70 to 0.91. All scales
in the American sample met the criterion for internal
www.futuremedicine.com 161
Review Nguyen, Popovic, Chowet al.

consistency. The same did not apply for the systemic
therapy side effects scale and the arm symptoms scales
in the Dutch sample, nor for the three symptom scales
in the Spanish sample.
Cronbachs coefficient for the nine-item BCS
ranged from 0.69 to 0.86, while for the FACT-B, the
coefficient for the entire instrument was 0.90, highlight-
ing the advantage of the conjunctive use of the BCS and
the FACT-G. Test-retest reliability coefficients were
0.88 for the BCS and 0.85 for the FACT-B total score,
reflecting the tests stability across administrations[14] .
Characteristics
A direct comparison of the QLQ-BR23 and FACT-B
with regards to characteristics can be found on Table2.
Administration of the QLQ-BR23 and the QLQ-C30
is 53 items long, whereas the FACT-B is markedly
shorter, containing 37 items.
Subscales
The QLQ-BR23 assesses two functional scales: body
image (four items) and sexuality (three items), as well
as three symptom scales addressing the arm/hand
(three items), the breast (four items) and systemic side
effects (eight items), while the remaining item grades
future perspective. In comparison, the most recent
version of the FACT-B addresses PWB (seven items),
SWB (seven items), EWB (six items) and FWB (seven
items), as well as the BCS, which focuses on concerns
specifically relevant to breast cancer patients.
Content
Within the physical domain, overlapping items address
lack of energy, nausea, general pain, fatigue, dyspnea,
alopecia and arm symptoms. Unique to the FACT-B
are two items, feeling ill and being bothered by side
effects of treatment. In the QLQ-BR23, unique items
address the presence of constipation, headaches, hot
flushes and breast symptoms. Although these diverg-
ing items are treatment side effects, the EORTC pair
paints a much more comprehensive picture of the
patients physical status in that it notes more numer-
ous physical symptoms in more detail and ties them
together with how they would affect daily life.
Within the functional domain, while both question-
naires address sleeping, being limited at work and being

Table 2. Comparison of the European Organisation for Research and Treatment of Cancer Quality of Life
Questionnaire for Patients with Breast Cancer and the Functional Assessment of Cancer Therapy Quality of Life
Measurement of Patients with Breast Cancer in Terms of Characteristics.
EORTC QLQ-BR23 FACT-B
Purpose To address QoL issues relevant to breast To address QoL issues relevant to breast
cancer patients not addressed within the cancer patients not addressed within
EORTC QLQ-C30 the FACT-G
Number of items on core + supplement 30 + 23=53 27 + 10=37
Response options Likert Scale (14 inclusive) Likert Scale (04 inclusive)
Recall period During the prior week (with exception During the prior week
to items considering sexuality, for which
the recall period is the prior month)
Item format Questions Statements
Item organization Items grouped into subscales Items grouped into subscales
Assessed subscales (in order) Systemic symptoms Physical well-being
Body image Social/family well-being
Sexuality Emotional well-being
Arm-related symptoms Functional well-being
Breast-related symptoms Additional concerns (breast
cancer-specific subscale)
Subscale components Multi-item subscales Multi-item subscales
Scoring The scores are linearly converted to Scores are summated to create subscale
a 0100 scale, where higher function and overall scores. A Trial Outcome
scores reflect improved function and Index is generated via the addition of
higher symptom scores present a higher the physical well-being, functional
level of symptoms well-being, and breast cancer subscales
QoL:Quality of life.

162 J.Comp. Eff. Res. (2015) 4(2) future science group

 EORTC QLQ-BR23 & FACT-B for the assessment of quality of life in patients with breast cancer
forced to stay in bed, the FACT-B distinctly addresses
the enjoyment of hobbies and life, contentment with
current QoL, disease acceptance and trouble meeting
needs of family while the EORTC pair address inde-
pendence in eating, dressing and self-washing and
ability to perform strenuous activities. Based on the
previous comparative analysis, the FACT-B integrates
a more social and personal angle to functioning.
Within the emotional scale, both questionnaires
focus on sadness, worry and future perspective.
Although the EORTC pair provides more detail in
the physical domain, the FACT-B is more extensive
in assessing emotional well-being as it notes sadness
rather than depression (the word depression often
introduces a certain degree of stigma), satisfaction in
coping with illness, hope in fighting against illness,
worry about death and other members getting the
same illness within the future and the effect of stress
on disease, whereas the EORTC questionnaires merely
note tension, worry, depression, irritability and worry
about future general health.
While the QLQ-BR23 inquires about interest in sex,
sexual activity and enjoyment, the FACT-B condenses
those three items into an arguably more relevant state-
ment: I am satisfied with my sex life. The FACT-B
also distinctly assesses whether the patient feels sexually
attractive.
The FACT-B provides a more in-depth analysis of
the patients social well-being as it covers many social
facets such as perceived closeness to friends and part-
ners, support from family and friends, disease accep-
tance on the part of the family, family communication
and worry that family may someday suffer the same ill-
ness. On the other hand, the social scope of the QLQ-
C30 is narrowed down to treatment-related interference
on family life, social activities and treatment-induced
financial difficulties.
With regards to body image, while both sets of ques-
tionnaires consider feelings of femininity and attractive-
ness, only the FACT-B evaluates self-consciousness in
how the patient is dressed and to what extent the patient
is bothered by weight change. Furthermore, only the
QLQ-BR23 assesses whether the patient finds it diffi-
cult to look at her/his naked self as well as dissatisfaction
of his/her body.
Format
Both questionnaires employ Likert scales, with scoring
from 1 (not at all) to 4 (very much), inclusive in
the QLQ-BR23 and 0 (not at all) to 4 (very much),
inclusive in the FACT-B. The recall period is the prior
week for the entire FACT-B and QLQ-C30 but only
for the first 13 questions and last 7 questions in the
QLQ-BR23. The remaining three items, which relate
future science group
Review
to sex, are recalled over the previous month. In both
questionnaires, the items are grouped according to
subscale. This is explicitly shown within the FACT-B,
whereas the QLQ-BR23 items are explicitly grouped
based on recall period and covertly grouped based on
the subscale assessed. Each item is presented as a ques-
tion within the QLQ-BR23 and as a statement within
the FACT-B.
Scoring
The raw scale and single-item scores on the QLQ-
BR23 are linearly converted to a 0100 scale. For
the functional scales and single items (body image,
sexuality and future perspective), higher scores reflect
improved function, whereas for the symptom scales,
higher scores represent worse symptom levels.
Conversely, scoring of the FACT-B simply requires
summation of raw scores. Higher scores represent
improved global QoL. Because the FACT-B items
are formatted as statements, negatively phrased items
require reverse response scores. There are three scor-
ing options: the FACT-B total score, the BCS score
and finally, the Trial Outcome Index (TOI; sum of
the PWB, FWB and BCS scores). The TOI provides a
summary index of overall physical function.
Discussion
The EORTC QLQ-BR23 and the FACT-B are the
only QoL questionnaires that have been devised specif-
ically for breast cancer patients facing differing disease
stages and treatments. Both tools act as supplements
to their general cancer questionnaires, the EORTC
QLQ-C30 and the FACT-G, respectively. However,
there are no consistent present-day sets of guidelines
that are used to facilitate decision-making between the
available QoL modules. As such, the purpose of this
article was to review the development, characteristics,
validity and reliability of the EORTC QLQ-BR23 and
the FACT-B.
Ideally, QoL questionnaires should possess the fol-
lowing characteristics: brevity, feasibility, validity, reli-
ability, comprehensiveness and clarity. In large scale
testing of the FACT-B and the QLQ-BR23, both
questionnaires were well received for their brevity. In
comparison to the QLQ-BR23, the FACT-B is shorter
by 16 items (Table2) . Interestingly, although the
FACT-B comprises fewer items than the QLQ-BR23
and QLQ-C30, it takes a slightly longer time to com-
plete the FACT-B than the EORTC pair (10 vs 9 min,
respectively)[10,14] .
Both questionnaires were feasible; although 19%
of women who participated within the large-scale test-
ing of QLQ-BR23 found the questions relating to
sex too intrusive or did not complete them. No issues
www.futuremedicine.com 163
Review Nguyen, Popovic, Chowet al.

regarding sex-related items were described in the devel- the physical symptoms scales within the QLQ-BR23
opment of the FACT-G by Cellaetal. [15] ; however, and the social and emotional well-being scales within
this may be due to the fact that the FACT-B only the FACT-B, despite both questionnaires respectively
dedicates one item to sex (I am satisfied with my sex emphasizing those particular scales. The inverse rela-
life), which is independent of whether the patient is tionship between scale comprehensiveness and internal
sexually active. The QLQ-BR23 rather addresses three consistency is understandable in that scale extensive-
sex-related items that are all dependent on whether the ness usually entails a broader range of questions and
patient has been sexually active and thus may appear thus potentially weakened internal consistency.
more intrusive. Both questionnaires have been considered more
Sprangersetal.[10] showed that the symptom scales beneficial within certain treatment populations,
of the QLQ-BR23 generally did not meet the 0.70 introducing limitations of applicability. For example,
Cronbachs alpha criterion for internal consistency, Chen etal. [28] noted that both questionnaires were
while Bradyetal. [14] found Cronbachs coefficient limited in their ability to detect clinically meaning-
to be inadequate only for the SWB, EWB and BCS ful changes arising from surgical interventions, as
subscales of the FACT-B. Interestingly, unsatisfac- their items are more related to chemotherapy-related
tory internal consistency was generally found within symptoms. In addition, our literature search revealed
Executive summary
Breast cancer is the second leading cause of death amongst females and prevails as the one of the most
common cancers worldwide.
Prognosis, survival and physical symptoms are not the sole concerns of breast cancer patients as they also face
psychosocial morbidity linked to cosmetic alterations derived from treatment and the cancer itself.
Given the increased survival rates and awareness of both the physical and emotional toll in breast cancer, the
importance of assessing quality of life (QoL) as a primary end point in such a patient population has surged
greatly.
QoL is now an established prognostic indicator in breast cancer.
The main objective of this literature review is to compare two widely used QoL assessment tools in the breast
cancer population, the EORTC QLQ-BR23 and the FACT-B.
This review summarizes the literature on the two tools with respect to their development, characteristics,
validity, reliability and use worldwide.
Development
Both questionnaires were developed through patient interviews, literature searches and expert opinion.
Formal item reduction resulted in 23 items for the QLQ-BR23 (which is paired with its 30 item general cancer
questionnaire [QLQ-C30]) and 10 items for the Breast Cancer Subscale (which is administered with its general
questionnaire [FACT-G], together forming the 37-item FACT-B).
In Phase IV of development, the QLQ-BR23 was tested amongst 218 Dutch patients, 176 Spanish patients and
158 American patients while the FACT-B was tested amongst two samples totaling 342 American patients.
Characteristics
Scoring, item format, organization and response options differ between the two questionnaires, while the
recall period for both is within the previous week with exception of items relating to sexuality within the
QLQ-BR23.
Both tools were well-received for their brevity completion time for the FACT-B and the EORTC pair is 10 vs
9min, respectively.
While the QLQ-BR23 centers more on analysis of physical symptoms and function, the FACT-B sheds more
emphasis on psychosocial and emotional well-being.
Reliability & validity
The symptom scales of the QLQ-BR23 did not meet the criterial Cronbachs coefficient of 0.70, while the
same was found for the SWB, EWB and the BCS subscales of the FACT-B.
Validation of both questionnaires was appraised in multiple ways and both questionnaires were generally
found to be sensitive to performance status.
Use worldwide
The EORTC QLQ-BR23 was found to be more prominently utilized in conventional intervention-related
trials, while the converse applied for the FACT-B, which took precedence in complementary and alternative
intervention trials.
Conclusion
Although both questionnaires differ in their focal points, decision-making between the questionnaires should
be based on study purpose/design.

164 J.Comp. Eff. Res. (2015) 4(2) future science group

 EORTC QLQ-BR23 & FACT-B for the assessment of quality of life in patients with breast cancer
that the FACT-B has been used primarily in comple-
mentary and alternative intervention trials, while the
EORTC QLQ-BR23 has been favored in conventional
intervention-related trials (Table1) . This finding may
be explained by the differing emphases of both the
FACT-B and the EORTC QLQ-BR23 on emotional
well being and physical function, respectively.
In the future, it is likely that QoL measures for breast
cancer will not be limited to the EORTC QLQ-BR23
and the FACT-B. For example, the NIH Dynamic
Tools to Measure Health Outcomes from the Patient
Perspective (PROMIS) initiative has developed various
modules for valid and reliable assessment of patient-
reported health, including QoL[29] . Recently, PRO-
MIS unveiled a study analyzing cancer-specific tools
that are psychometrically valid and equivalent across
diverse cancer populations; currently, diverse breast
cancer participants are also enrolled.
Conclusion
The concept of QoL has been vastly recognized for its
prognostic role in treatment and disease outcomes[30] .
Although the EORTC QLQ-BR23 and the FACT-B
differ in their focal points, both questionnaires have
been proven to be valid, reliable and prominent tools in
breast-cancer specific QoL assessment. This review is
limited in that it mainly centered on initial validation
papers. Although it delved into many aspects of the two
questionnaires, this review did not fully examine their
use in current clinical trials. Nonetheless, this review
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Financial & competing interests disclosure
The authors thank the generous support of Bratty Family Fund,
Michael and Karyn Goldstein Cancer Research Fund, Pulenzas
Cancer Research Fund, Joseph and Silvana Melara Cancer Re-
search Fund and Ofelia Cancer Research Fund. The authors
have no other relevant affiliations or financial involvement
with any organization or entity with a financial interest in or
financial conflict with the subject matter or materials discussed
in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this
manuscript.
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